Principal Software Quality Engineer
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
Tempus is looking for a Principal Software Validation Engineer who is responsible for ensuring compliance to GxP computer system validation, and for authoring related documentation such as policies, procedures, risk assessments, validation plans, URS, test protocols and reports.
- Leading risk-based approach to computer system validation (CSV).
- Developing and maintaining CSV and FDA CFR 21 Part 11 policies, procedures, templates and work instructions.
- Performing validation of OTS and in-house developed host systems such as LIMS (Laboratory Information Management System), MDDS (Medical Device Data System), enterprise systems (CRM, ERP), eQMS (Quality Management System/Doc Control System e.g. ETQ), LMS, SDLC Tools.
- Providing input and collaborating with the product team in developing test-driven software requirements, and supporting test execution.
- Authoring and reviewing software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.
- Participating in the change management process as validation lead.
- Supporting Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.
- Providing CSV guidance, coaching, mentorship, and training to test engineers within the team.
- Perform other related duties and responsibilities as needed.
Required Education & Experience:
- MS in a Computer Science or Engineering field or equivalent experience.
- 5+ years experience in FDA regulated domains (e.g. medical device, pharma, biotech) .
- 7+ years experience in Computer System Validation (CSV), and FDA 21 CFR Part 11.
- Experience with general principles of software validation and GAMP 5.
- Knowledge of quality system principles (GxP), practices, and standards for the life science industry.
- Project management skills including planning, estimation and requirements management.
- Experience with SDLC tools such as Atlassian Suite (Jira, Confluence, Zephyr etc), Jama, Github and Jenkins.
- Excellent organizational, interpersonal, verbal and written communication skills.
- Able to evaluate situations, apply critical thinking skills, and propose potential solutions.
- Ability to deliver quality outputs without directions or supervision.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.